Software Quality Engineer

  • Full-time
  • Engineering
  • Mid-level

Job summary

The ideal candidate will gather requirements, create test plans, test cases, define and implement test strategies, and test medical device software, in accordance with industry standards and regulations.

The role

  • Establish test methodologies and acceptance criteria, execution of test protocols, data analysis, investigation, and writing final reports
  • Analyze system requirements and develop test plans, cases and excute on these requirements
  • Partner with engineering team to document and refine requirements
  • Good technical writing skills, including development of test methods, protocols, reports.
  • Facilitate documentation and tracking of verification activities
  • Assess and evaluate new tools and testing methodologies
  • Generate defect reports in defect tracking system and verification of correct technical fixes using such systems as Jira, ClearQuest, Helix ALM, etc.
  • Perform regression analysis/testing and associated documentation on software release changes
  • Demonstrate understanding of complete software development lifecycle phases
  • Experience in a team oriented traditional waterfall or fast-paced agile development processes, working closely with developers during feature development and testing phases
  • Develop and implement quality metrics associated with software development and performance


  • Bachelor’s degree in relevant engineering discipline or equivalent experience. BS with a Computer Science concentration, preferred. MS preferred
  • Minimum of three to five (3-5) years’ experience with relevant and recent experience performing the same or similar type of work as required by the position in compliance with the recognized standards below.
  • Class I, II and III medical device verification and validation experience or equivalent
  • Working knowledge and/or understanding of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971
  • Experience with defect tracking and metrics
  • Experience with requirements management software such as Helix ALM, Jama or Doors
  • Proficient computer skills with applicable software packages (e.g. Microsoft Office, Matlab, Excel, etc.)